Prospective RCT Comparing Perioperative Pain

Preoperative Interscalene Nerve Block Plus Postoperative Local Intra-operative Analgesic Injection vs Preoperative Interscalene Nerve Block Plus Postoperative Saline Injection in Patients Undergoing Shoulder Arthroplasty: a Randomized Trial

This study is a non-blinded randomized controlled trial comparing the use of a preoperative "mini" block plus postoperative local infiltration of Exparel (liposomal form of bupivacaine) versus a partial single shot nerve block in subjects undergoing primary reverse or total shoulder arthroplasty to see which is more effective in controlling surgery related pain. To do so, we will utilize the Visual Analog Scale (VAS) to measure pain intensity. Opioid consumption will be recorded on a Pain Monitoring Sheet.

Study Overview

• Status: Completed
• Conditions: Arthroplasty Shoulder
• Intervention / Treatment: Drug: Saline; Drug: Bupivacaine liposome

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Thomas Jefferson University Hospital, Methodist Hospital or Rothman Specialty Hospital.

Exclusion Criteria:

• Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia
• Revision arthroplasty or arthroplasty for fracture
• Unable/unwilling to consent for enrollment
• Unable to complete postoperative pain survey
• Known adverse drug reaction or allergy to the medications used
• Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain)
• Patients taking long acting opioid pain medications (including extended release opioid pain medications and methadone)
• Patients under the age of 18 years
• Patients with history of hepatic disease
• Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Preoperative block plus saline; Preoperative interscalene brachial plexus single-shot block using 25ml of 0.5% Ropivicaine plus postoperative 40cc local infiltration of saline	Drug: Saline; A preoperative interscalene brachial plexus single-shot block using 25 ml of 0.5% Ropivicaine plus saline injection postoperative
Active Comparator: Preoperative block plus Bupivacaine extended-release liposome; Interscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues)	Drug: Bupivacaine liposome; an interscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
morphine and morphine equivalent consumption	24 hours post surgery

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics
• Investigators: Principal Investigator: Surena Namdari, MD, Rothman Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2017SNam

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No